Engineering ManagerProduction Engineering Manager onsite

Benefits:

• Bonus based on performance
• Company parties
• Competitive salary
• Dental insurance
• Donation matching
• Health insurance
• Paid time off
• Vision insurance
• Wellness resources

Sigma Stim is a small medical electronics company that has been in business for 45 years. We an excellent working environment that prioritizes work-life balance. We attract high-level talent who are able to manage themselves and have superior experience and expertise. This is a position for someone who enjoys to staying busy with research and development and troubleshooting projects. There is rarely a dull moment, and our team encourages a large amount of collaboration so this is an on-site engineering position.

• Bachelor of Science degree in an engineering discipline or applicable college studies along with at least five years of relevant job experience
• Direct responsibility for engineering projects, design changes, upgrades, component selection, and associated documentation
• Analog and digital electrical circuit design experience
• Oversee creation and maintenance of electrical schematics, Printed Circuit Board (PCB) layout files, and mechanical/assembly drawings using Computer Aided Design (CAD) tools
• Create, execute, and maintain test protocols for devices, subassemblies, accessories, and in-house test and measurement equipment.
• Accountable for test and measurement equipment calibration and verification utilized by the engineering, production, and service teams.
• Manage, monitor, and document production processes to ensure regulatory compliance and continuous improvement
• Function as the principal point of contact for resolving production process challenges and personnel matters
• Ability and knowledge to help the production and service team troubleshoot challenging device failures
• Some level of coding skills to help with the development of code

• Knowledge of ISO 13485, MDSAP, FDA, EU MDR regulations, and IEC 60601 collateral electrical standards
• Knowledge of REACH and RoHS EU Regulations
• Medical device manufacturing experience
• Experience in risk management and analysis (ISO 14971)
• Knowledge of design optimization for manufacturability and design transfer to production
• Component‑level troubleshooting of PCB assemblies to resolve technical issues
• Provide and document customer support through phone, email, and video conferencing, ensuring clear communication and long‑term reliability; elevate and notify executive management when necessary to address critical issues

• Printed Circuit Board PCB layout experience
• Mechanical component design experience using CAD tools
• Firmware and embedded systems software development utilizing C, C++, and Assembly languages
• REACH & RoHS regulation knowledge and experience setting up maintenance system
• Execute medical device manufacturing tasks including assembly, quality assurance, testing, and rework of subassemblies and finished devices